Label: FEXOFENADINE HYDROCHLORIDE tablet

  • NDC Code(s): 69842-052-02, 69842-052-07, 69842-052-15, 69842-052-18, view more
    69842-052-29, 69842-052-30, 69842-052-40, 69842-052-45, 69842-052-60, 69842-052-70, 69842-052-90
  • Packager: CVS Health Corp.
  • This is a repackaged label.
  • Source NDC Code(s): 55111-784
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 20, 2021

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  • Active ingredient (in each tablet)

    Fexofenadine HCl USP, 180 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat



  • Warnings

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have

    kidney disease. Your doctor should determine if you need a different dose.

    When using this product

    • do not take more than directed
    • do not take at the same time as aluminum or magnesium antacids
    • do not take with fruit juices (see Directions)

    Stop use and ask doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of  overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years of age and over         take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
    children under 12 years of agedo not use
    Adults 65 years of age  and olderask a doctor
    consumers with kidney diseaseask a doctor
  • Other information

    • (Bottle only)-safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
    • (Blister only)- Safety sealed: Do not use if seal is broken or if individual blister unit is torn or open
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • this product meets the requirements of USP Dissolution Test 2

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide.

  • Questions?

    Call 1-888-375-3784

  • Carton label

    Carton Label: 40 count

    CVS Health

    Compare to the active ingedient in
    Allegra® Allergy 24 Hour Tablets*

    Indoor & Outdoor Alllergies

    Original Prescription Strength

    Allergy Relief

    FEXOFENADINE HYDROCHLORIDE
    TABLETS USP, 180 MG

    24 Hour Relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy nose or throat

    Non-Drowsy 24 HOUR

    Actual Bottle Size on Bottom Panel

    Package Contains One Bottle

    40 TABLETS 180 mg EACH

    Carton

  • Bottle Label

    Bottle Label: 40 count

    CVS Health

    Compare to the active ingedient in
    Allegra® Allergy 24 Hour Tablets*

    Indoor & Outdoor Alllergies

    Original Prescription Strength

    Allergy Relief

    FEXOFENADINE HYDROCHLORIDE
    TABLETS USP, 180 MG

    24 Hour Relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy nose or throat

    Non-Drowsy 24 HOUR

    Actual Bottle Size on Bottom Panel

    Package Contains One Bottle

    40 TABLETS 180 mg EACH

    Bottle

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-052(NDC:55111-784)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) Fexofenadine Hydrochloride180 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize7mm
    FlavorImprint Code 194;R
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-052-301 in 1 CARTON04/01/2011
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69842-052-901 in 1 CARTON04/01/2011
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69842-052-401 in 1 CARTON05/01/2013
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69842-052-451 in 1 CARTON04/01/2011
    445 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69842-052-602 in 1 CARTON04/01/2011
    560 in 1 CARTON; Type 0: Not a Combination Product
    6NDC:69842-052-181 in 1 CARTON02/01/2013
    6180 in 1 CARTON; Type 0: Not a Combination Product
    7NDC:69842-052-021 in 1 CARTON04/01/2015
    72 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:69842-052-071 in 1 CARTON04/01/2011
    85 in 1 BLISTER PACK; Type 0: Not a Combination Product
    9NDC:69842-052-153 in 1 CARTON04/01/2011
    95 in 1 BLISTER PACK; Type 0: Not a Combination Product
    10NDC:69842-052-293 in 1 CARTON04/01/2011
    1015 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:69842-052-701 in 1 CARTON01/11/2019
    1170 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07650204/01/2011
    Labeler - CVS Health Corp. (062312574)
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